(164 days)
The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system's chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use.
The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in the quantitative determination of sodium, potassium and chloride (Na, K, Cl) in human serum, plasma and urine using the Trinidad CH System. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The TD-LYTE IMT Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System.
The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na. K, and Cl on the Trinidad CH System.
The Albumin BCP Reagent (Alb) P) is intended for in the quantitative measurement of albumin in human serum or plasma on the Trinidad CH System. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The Albumin BCP calibrator is for in vitro diagnostic use in the Trinidad CH Albumin BCP Assay (Alb P) on the Trinidad CH System.
The Siemens Healthcare Diagnostics Trinidad CH System is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric and integrated ion selective multisensor detection technologies for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).
Na, K, Cl uses indirect Integrated Multisensor Technology (IMT). There are four electrodes used to measure electrolytes. Three of these electrodes are ion selective for sodium, potassium and chloride. A reference electrode is also incorporated in the multisensor.
A diluted sample (1:10 with IMT Diluent) is positioned in the sensor and Na*, K* or Cl ions establish equilibrium with the electrode surface. A potential is generated proportional to the logarithm of the analyte activity in the sample. The electrical potential generated on a sample is compared to the electrical potential generated on a standard solution, and the concentration of the desired ions is calculated by use of the Nernst equation.
Serum, plasma and urine specimens may be used. The sensor is stored unopened at 2 – 8 °C and is stable for use on board for 14 days or 5000 samples.
The Trinidad CH System TD-LYTE Integrated Multisensor system performs a two point automatic calibration in duplicate every 4 hours. In addition, the system will routinely perform a one point calibration check with each sample measurement. Auto-calibration occurs after power-on, with the changing of standards A. B. or a sensor and when the system software is reset.
The target concentrations of the TD-LYTE IMT Standard A include: Nat at 14 mmol/L, K* at 0.4 mmol/L and Cl¯ at 10.4 mmol/L. The target concentrations of the TD-LYTE Standard B include: Na 7 mmol/L, K* at 6 mmol/L and Cli at 16 mmol/L. The target concentrations of the Salt Bridge include: K* at 120.0 mmol/L and Cl¯ at 120.3 mmol/L.
The Trinidad CH System Albumin BCP Reagent (Alb_P) assay is an adaptation of the bromocresol purple (BCP) dye-binding method reported by Carter and Louderback, et al. In the Trinidad CH System , the Alb_P assay, serum or plasma albumin quantitatively binds to BCP to form an albumin-BCP complex that is measured as an endpoint reaction at 596/694 nm.
Alb P is calibrated with Trinidad CH Diluent(11099300) and ALBP Calibrator (1 level). It is a 2-point linear curve.
Serum and plasma specimen types may be used. The reagent is stored at 2 - 8 °C and each well is stable on the sytem for 20 days.
The Albumin BCP (Alb P) calibrator is a lyophilized human serum-based product containing albumin. It is used to calibrate the Albumin BCP (Alb_P) assay on the Trinidad CH System.
The target concentration of the albumin is 4.3 g/dL.
The provided document describes the Siemens Healthcare Diagnostics Trinidad CH System and its associated assays for Sodium (Na), Potassium (K), Chloride (Cl), and Albumin (Alb_P). The document is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to predicate devices. It presents various performance characteristics of the device.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a single, consolidated table with pass/fail results. Instead, it presents performance data for various characteristics, and the underlying implication is that these results are acceptable for demonstrating substantial equivalence. The following table summarizes the reported performance characteristics:
| Performance Characteristic | Analyte | Specimen Type | Acceptance Criteria (Implied) | Reported Device Performance (Trinidad CH System) |
|---|---|---|---|---|
| Detection Limit (LoB) | Na | Serum | Low value desirable | 10.2 mmol/L |
| K | Serum | Low value desirable | 0.244 mmol/L | |
| Cl | Serum | Low value desirable | 2.23 mmol/L | |
| Na | Urine | Low value desirable | 4.72 mmol/L | |
| K | Urine | Low value desirable | 0.00 mmol/L | |
| Cl | Urine | Low value desirable | 4.86 mmol/L | |
| Albumin (Alb_P) | Serum | Low value desirable | 0.1 g/dL | |
| Detection Limit (LoD) | Na | Serum | Low value desirable | 11.9 mmol/L |
| K | Serum | Low value desirable | 0.279 mmol/L | |
| Cl | Serum | Low value desirable | 4.43 mmol/L | |
| Na | Urine | Low value desirable | 5.30 mmol/L | |
| K | Urine | Low value desirable | 0.079 mmol/L | |
| Cl | Urine | Low value desirable | 5.47 mmol/L | |
| Albumin (Alb_P) | Serum | Low value desirable | 0.2 g/dL | |
| Quantitation Limit (LoQ) | Na | Serum/Plasma | Westgard model TE | 40.4 mmol/L (4.8% TE) |
| Na | Urine | Westgard model TE | 5.35 mmol/L (1.78 mmol/L or 27% TE) | |
| K | Serum/Plasma | Westgard model TE | 0.792 mmol/L (16.3% TE) | |
| K | Urine | Westgard model TE | 1.03 mmol/L (22% TE) | |
| Cl | Serum/Plasma | Westgard model TE | 38.3 mmol/L (10.3% TE) | |
| Cl | Urine | Westgard model TE | 15.8 mmol/L (16% TE) | |
| Albumin (Alb_P) | Serum | Inter-assay precision |
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.